Actively Recruiting
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia
Led by MapLight Therapeutics · Updated on 2026-03-09
300
Participants Needed
25
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
ML-007C-MA-211 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered ML-007C-MA in inpatient adult participants aged 18 to 64 years with schizophrenia experiencing an acute exacerbation of psychosis. The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.
CONDITIONS
Official Title
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary diagnosis of schizophrenia confirmed by DSM-5 criteria using a clinical interview
- Experiencing an acute worsening of schizophrenia symptoms within 2 months before screening
- If hospitalized for acute schizophrenia exacerbation, inpatient for less than 2 weeks at screening start
- Schizophrenia symptoms at least moderate and persistent at screening and baseline based on PANSS and CGI-S
- Willing and able to stay inpatient and follow study instructions throughout the study duration
You will not qualify if you...
- Diagnosis of any DSM-5 disorder other than schizophrenia within 12 months before screening that causes current symptoms or impairment
- Psychiatric hospitalization(s) totaling more than 30 days in the 90 days before screening, or current involuntary hospitalization or incarceration
- Use of any antipsychotic medication or prohibited therapy during screening period unless stopped before baseline
- Clinically significant or unstable medical conditions at screening or baseline
- Elevated risk of suicidal behavior
- Known or likely allergy or severe reaction to ML-007C-MA or related substances
- Moderate to severe substance use disorder (except tobacco or caffeine) within 12 months before screening
- Participation in another clinical trial involving investigational or marketed drugs, biological products, or devices within 90 days before baseline
- Previous participation in a study with ML-007
- Elevated risk of violent or destructive behavior based on history and investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 25 locations
1
Clinical Site
Little Rock, Arkansas, United States, 72211
Actively Recruiting
2
Clinical Site
Bellflower, California, United States, 90706
Actively Recruiting
3
Clinical Site
Culver City, California, United States, 90230
Actively Recruiting
4
Clinical Site
Garden Grove, California, United States, 92845
Actively Recruiting
5
Clinical Site
Lemon Grove, California, United States, 91945
Actively Recruiting
6
Clinical Site
Los Angeles, California, United States, 90015
Actively Recruiting
7
Clinical Site
Montclair, California, United States, 91763
Active, Not Recruiting
8
Clinical Site
Orange, California, United States, 92868
Actively Recruiting
9
Clinical Site
Riverside, California, United States, 92506
Actively Recruiting
10
Clinical Site
San Diego, California, United States, 92123
Actively Recruiting
11
Clinical Site
Santee, California, United States, 92071
Withdrawn
12
Clinical Site
Sherman Oaks, California, United States, 91403
Actively Recruiting
13
Clinical Site
Torrance, California, United States, 90504
Actively Recruiting
14
Clinical Site
Hollywood, Florida, United States, 33024
Actively Recruiting
15
Clinical Site
Miami Lakes, Florida, United States, 33016
Active, Not Recruiting
16
Clinical Site
West Palm Beach, Florida, United States, 33407
Actively Recruiting
17
Clinical Site
Atlanta, Georgia, United States, 30331
Actively Recruiting
18
Clinical Site
Decatur, Georgia, United States, 30030
Active, Not Recruiting
19
Clinical Site
Chicago, Illinois, United States, 60640
Actively Recruiting
20
Clinical Site
Marlton, New Jersey, United States, 08053
Actively Recruiting
21
Clinical Site
Staten Island, New York, United States, 10314
Actively Recruiting
22
Clinical Site
North Canton, Ohio, United States, 44720
Actively Recruiting
23
Clinical Site
Austin, Texas, United States, 78754
Actively Recruiting
24
Clinical Site
DeSoto, Texas, United States, 75115
Actively Recruiting
25
Clinical Site
Richardson, Texas, United States, 75080
Actively Recruiting
Research Team
C
Clinical Trials Contact Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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